AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 1, 2023

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

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Pharmaceutical Technology

FEBRUARY 20, 2023

If clinical trial participants are representative of the wider disease population, they can help sponsors assess the effectiveness of new and existing therapeutics. of the clinical trial population globally. This may sound obvious, but it is still a major hurdle in drug development. participation of white subjects.

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XTalks

APRIL 22, 2022

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry?

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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XTalks

NOVEMBER 7, 2022

Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. The greater the risk, the more likely a series of trials for market clearance or approval will be required. In other words, what are the risks and benefits of the product?

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XTalks

MARCH 27, 2024

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. Dr. Dhiman has 24 years of clinical research experience in the immunogenetics of vaccines and infectious disease diagnostics. She did her clinical microbiology fellowship at Mayo Clinic in Rochester, Minnesota.

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pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

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Advarra

JULY 18, 2023

Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) requirements ( 21 CFR 812 ). Regardless of how the IVD results are used in the study, if SR sampling procedures are used, the clinical trial is SR.

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Drug Discovery World

APRIL 25, 2023

University of California researchers have dosed the second participant in their clinical trial to identify a potential cure for HIV utilising CAR-T cell therapy. The trial is the first-in-human clinical study investigating the duo CAR-T cell therapy for the treatment of HIV. In 2021 there were an estimated 1.5

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Drug Discovery World

AUGUST 7, 2023

DDW’s Reece Armstrong speaks to Shantanu Dhamija , VP of Strategy and Innovation at Molecular Devices about challenges of diversity in clinical trials and why induced pluripotent stem cells might be key to representing wider patient groups. RA: Why is US clinical trial diversity at its lowest point in the last 10 years?

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The Pharma Data

APRIL 22, 2023

UC Davis Health researchers have dosed the second participant in their clinical trial looking to identify a potential cure for HIV utilizing CAR T-cell therapy. The trial is the first-in-human clinical study investigating the duoCAR T-cell therapy for the treatment of HIV. The novel study uses immunotherapy.

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Pharmaceutical Technology

MAY 31, 2023

ZNA-1041 is under clinical development by F. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Buy the report here.

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Drug Discovery World

JANUARY 24, 2024

DDW’s Megan Thomas caught up with Wigerinck to learn more about his work with small molecules for fibrosis research. MT: Your appointment comes as Fibrocor seeks to advance two drug candidates – exquisitely specific kinase inhibitor small molecules (FIB992 and FIB991) for rare indications into the clinic.

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XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.

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Advarra

SEPTEMBER 23, 2022

The FDA requires the data for these assessments to generally come from animal studies and clinical investigations 1 of the investigational product(s) 2. . In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. .

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Advarra

APRIL 19, 2023

In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., IVDs are used in almost all clinical research. IVDs are used in almost all clinical research. However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants.

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Drug Discovery World

OCTOBER 27, 2023

Organ-chips combine cell culture with microfluidics to emulate the biological forces of different organ tissues and/or disease states, allowing pharmaceutical researchers to determine a drug candidates’ efficacy and toxicity ahead of clinical trials. Could organ-chips replace other research methods?

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XTalks

FEBRUARY 1, 2023

Researchers at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London have found that a blood test could aid in the early detection of Alzheimer’s disease up to three and a half years before diagnosis. Alzheimer’s affects neurogenesis in the hippocampus during the early stages of the disease.

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Drug Discovery World

JUNE 12, 2023

At the American Association of Cancer Research’s Annual Meeting in Orlando, Florida, DDW’s Megan Thomas met with industry experts to learn more about their research and careers in the field of cancer research. Thomas speaks with Dennis Brown, Chief Scientific Officer at Kintara Therapeutics.

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Drug Discovery World

FEBRUARY 16, 2024

DDW recently hosted an online event, sponsored by Taconic Biosciences, which outlined areas of advancement and opportunity in the cancer research market. New drug discovery and development concepts The event started with a panel discussion on new drug discovery and development concepts and tools in cancer research.

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Drug Discovery World

FEBRUARY 15, 2023

The first such research dates back to 1891, when William Coley attempted to inject heat-inactivated bacteria to treat osteosarcoma. This is an exciting field of cancer research which involves harnessing the body’s own immune system to target cancerous cells. This continues to be the standard of care.

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Drug Discovery World

APRIL 8, 2024

The American Association of Cancer Research (AACR) Annual Meeting launched on Sunday 7 April in San Diego with an Opening Plenary Session showcasing cutting-edge technological advances opening new frontiers in cancer science.

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The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “We

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The Pharma Data

MAY 3, 2021

DARS also greatly expanded its clinical trials operations, running three clinical trials related to streamlining biosimilars development and studying safety questions related to opioids and over-the-counter drugs,” Strauss wrote. Posted 03 May 2021 | By Michael Mezher . 2020 was a challenging year.

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XTalks

APRIL 27, 2022

As an urgent situation stirred due to the pandemic, along with Veklury drugs such as ribavirin, penciclovir, favipiravir, nafamostat, nitazoxanide and chloroquine were evaluated in vitro for their antiviral efficiency against a clinical isolate of the novel coronavirus. Clinical Trial on Pediatric Patients.

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Advarra

AUGUST 31, 2022

If a new medical device, software as a medical device (SaMD), or in vitro diagnostic (IVD) is poised to successfully make it through the development process to commercialization, sponsors must consider a trifecta of interconnected systems involving: Regulatory strategy and submissions. Clinical evidence generation. Intended use.

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Pharmaceutical Technology

JUNE 5, 2023

Pralsetinib is under clinical development by F. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Buy the report here.

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The Pharma Data

OCTOBER 26, 2021

This is the first time that research scientists can conduct oncology research with Foundation Medicine’s comprehensive genomic profiling in their own laboratories to gain meaningful genomic insights and deepen their understanding of cancer biology. Roche today announced that it has launched the AVENIO Tumor Tissue CGP Kit.

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Roots Analysis

AUGUST 18, 2023

Animal testing is a vital part of drug development process, which is beneficial for researchers in understanding the cause, diagnosis, and treatment of various medical conditions. Due to this biological mismatch, several toxic drugs are subjected to costly clinical trials, while potentially useful drugs do not get commercialized.

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Drug Discovery World

APRIL 5, 2023

Italian research institute and contract research organisation IRBM has become the only company from outside the United States to join cancer drug discovery network the Chemical Biology Consortium (CBC). The post Only non-US company joins cancer drug discovery consortium appeared first on Drug Discovery World (DDW).

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Drug Discovery World

FEBRUARY 6, 2024

In vitro and in silico models are becoming increasingly sophisticated in predicting drug safety profiles and preventing costly and time-consuming clinical trials. In vitro and in silico models are becoming increasingly sophisticated in predicting drug safety profiles and preventing costly and time-consuming clinical trials.

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Roots Analysis

MAY 21, 2024

In allogeneic cell therapies, the cells are engineered ( to elicit a desired therapeutic response ) and amplified in-vitro. According to the Alliance for Regenerative Medicine, the number of clinical trials being conducted for allogeneic cell-based cancer therapies increased by 30% over the past five years.

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Drug Discovery World

MAY 9, 2023

Jantzen Sperry , PhD, Director of Scientific Operations at Certis Oncology looks at how the adoption of orthotopic PDX models can elevate the impact of cancer research and improve translation in oncology drug development. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

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The Pharma Data

JANUARY 13, 2021

Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

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Drug Discovery World

MAY 29, 2024

SpyBiotech and the University of Oxford Biotechnology company SpyBiotech and University of Oxford have entered a research agreement for the development of a vaccine against Epstein-Barr virus (EBV). Studies have found that EBV triggers a range of very serious health conditions including certain cancers and multiple sclerosis.

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Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

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